Research Update

    YM BIOSCIENCES REPORTS DAIICHI AND KUHNIL ENROL FIRST PATIENTS IN RANDOMIZED
PHASE II GASTRIC TRIAL

    - International Clinical Study Follows Promising Preclinical Data -

    MISSISSAUGA, ON, Sept. 30 /CNW/ - YM BioSciences Inc. (AMEX: YMI, TSX:
YM, AIM: YMBA), an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide, today announced
that two of its licensees for nimotuzumab, Daiichi-Sankyo Co., Ltd. in Japan
and Kuhnil Pharmaceutical Co. in Korea, advise that they have commenced the
enrollment in an 80-patient Phase II randomized, open-label trial of
nimotuzumab (400mg weekly until progression) plus irinotecan (150mg/m(2)
biweekly until progression) compared to irinotecan alone in patients with
advanced or recurrent gastric cancer who are refractory to 5-FU-containing
regimens. Enrollment is expected to be completed in calendar 2009.
    "This is great example of the progress being made by our multi-company,
multi-national consortium devoted to the development of nimotuzumab, and
demonstrates the evolution of cooperative trials for nimotuzumab," said David
Allan, Chairman and CEO of YM BioSciences. "A successful randomized trial in
this large, underserved indication would provide continued clinical evidence
of nimotuzumab's efficacy and its unique safety profile. The cooperative
efforts of Daiichi Sankyo and Kuhnil should speed patient recruitment in this
trial and allow the consortium to more rapidly advance nimotuzumab into
pivotal trials in this indication."
    The study was initiated following the demonstration of synergy between
nimotuzumab and irinotecan in the laboratories of Daiichi Sankyo in gastric
cancer cell lines. Both in-vitro and in-vivo experiments provided the
scientific rationale for this study.
    The primary endpoint of the study is to compare progression-free survival
between the two arms. Secondary endpoints include response rate (complete
responses + partial responses), disease control rate (complete responses +
partial responses + stable disease), duration of response, time to
progression, time to treatment failure and overall survival.
    YM BioSciences is concentrating its registration strategy on
radiation-containing regimens consistent with the research demonstrating a
preferential opportunity for nimotuzumab within such regimens. Designs for
YM's registration trials are expected to be completed in the final calendar
quarter. YM's concentration on radiation-containing regimens complements the
other trials in the consortium and expands the variety of treatment options in
which enhancement of cancer therapies by nimotuzumab is being tested.

    About Nimotuzumab

    Nimotuzumab is being developed to compete as best-in-class therapy
against the currently marketed EGFR-targeting drugs. This drug has displayed
efficacy in numerous clinical trials with anti-cancer activity that rivals the
other EGFR-targeting antibody drugs. However, in none of its trials to date,
to YM's knowledge, have any of the patients treated with nimotuzumab had Grade
III/IV rash, a severe and dose-limiting side-effect observed in all of the
other antibodies and with small molecules targeting the EGF tyrosine kinase
signaling pathway. Reports of any severe incidents of the other side-effects
that are typical of EGFR-targeting molecules have been rare. Unlike cetuximab,
nimotuzumab patients do not have to be pre-medicated to prevent infusion
reactions.
    YM and its direct licensees have studies underway and others in planning
that investigate nimotuzumab in settings where regimens that stimulate EGFR
activated expression are used, such as radiation or chemoradiation.

    About YM BioSciences

    YM BioSciences Inc. is a company that identifies, develops and
commercializes differentiated products principally in the area of oncology for
patients worldwide. The Company is developing nimotuzumab, a humanized
monoclonal antibody, and AeroLEF(R), a proprietary, inhaled-delivery
composition of free and liposome-encapsulated fentanyl. Nimotuzumab is in
development targeting multiple tumour types in combination with radiation,
chemoradiation and chemotherapy. The drug, which is approved for marketing in
eight countries, is significantly differentiated from all other currently
marketed EGFR-targeting agents because of a remarkably benign side-effect
profile. In approximately 3,000 patients treated worldwide, to date, no Grade
III/IV rash has been reported and reports of any of the other side-effects
that are typical of EGFR-targeting molecules have been rare. AeroLEF(R) is in
development for the treatment of moderate to severe pain, including cancer
pain. The product completed a randomized trial in 2007 and is being prepared
for late-stage development internationally.

    This press release may contain forward-looking statements, which reflect
the Company's current expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may cause
actual results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, but are not limited to,
changing market conditions, the successful and timely completion of clinical
studies, the establishment of corporate alliances, the impact of competitive
products and pricing, new product development, uncertainties related to the
regulatory approval process and other risks detailed from time to time in the
Company's ongoing quarterly and annual reporting. Certain of the assumptions
made in preparing forward-looking statements include but are not limited to
the following: that nimotuzumab will continue to demonstrate a competitive
safety profile in ongoing and future clinical trials; that AeroLEF(R) will
continue to generate positive efficacy and safety data in future clinical
trials; and that YM and its various partners will complete their respective
clinical trials within the timelines communicated in this release. We
undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.

   
For further information: Enquiries: Thomas Fechtner, the Trout Group LLC,
Tel. [phone], Email: tfechtner(at)troutgroup.com; James Smith, the
Equicom Group Inc., Tel. [phone] x 229, Email:
jsmith(at)equicomgroup.com; Nominated Adviser, Canaccord Adams Limited, Ryan
Gaffney, Tel. [phone]
(YMBA)


 



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